11 results
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20ms
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Sources: EU EUDAMED, US FDA
ITE HEARING AID, SOUND MED EMERALD MODEL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Brigade
FDA UDI
Nuvasive, Inc.·00887517962270·Brigade Lateral Trial, 12x34x28mm 25°
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
FDA 510(k)
FDA Class 1
·Microbiology
REDUC-FORC W/POINT SOFTLO L161
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTD·August 1, 2018
MINI TREK II OTW CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 30, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEA, AVENIDA HENEQUEN·Product code BTR·January 2, 2013
PRIDE MOBILITY PRODUCTS
FDA Adverse Event
Injury
·PRIDE MOBILITY PRODUCTS·Product code ITI·November 12, 2010
SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code MOL·June 23, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012